Putting Study Control Where It Belongs

IRT Essentials

“Patient-centric clinical trials” is a hot topic in the pharmaceutical industry today.

To be “patient-centric” is to consider in a new way the needs and realities of the patient experience, and to allow that understanding to inform your clinical trial all the way from study design through final visit.

The idea itself is simple — to proceed in a manner that is informed from the outset by what works and doesn’t work best for the patient (as opposed to the makers-of-protocols). The goal is to reduce dropout rates, to increase feasibility, and enhance patient satisfaction. By essentially shifting “power” to the patient, the potential for successful execution of a clinical trial is dramatically increased.

User Experience = Power+Simplicity!

IRT Essentials

The Challenge:

As technology gets more and more sophisticated, data collection systems for clinical trials are at risk of becoming less and less intuitive for users. Accordingly, the importance of the User Experience has moved to the forefront in many recent pharmaceutical conferences. The challenge for the pharma-tech industry is obvious: How to deliver more and more power under the hood while remaining/becoming more and more user friendly for the diverse population of users at clinical sites around the world?

Getting Data Sooner with IRT Part 2

Case Studies

The Challenge:

In a recent post (see hot topic “Getting Data Sooner”) we talked about how using a ‘give some, get some’ strategy in an IRT system contributes to getting your clinical trial data faster. Users are motivated to enter data in a timely fashion because use of the IRT is required for the site to get critical information required for study conduct and subject treatment — for example, their next kit number, or a dosing calculation. Visit data must be entered before the visit can be accomplished…as distinguished from an EDC system where data entry by the site can lag considerably behind.

But what about data that you want to capture in the IRT which doesn’t fit the ‘give some, get some’ strategy? For example, screen failure, early withdrawals, or receipt of drug shipments. For these kinds of data there is nothing the user requires from the system that would force them to do timely entry.

The Solution:

For instances like these, Veracity Logic’s VLIRT® system provides motivation by appealing to basic principles of human psychology… and by manipulating visit/response windows.

For example: When a subject fails screening, the subject obviously does not show up for their next visit. VLIRT® tracks visit status on the main Subjects page (the landing page for most studies) and turns the name and date of the next scheduled activity bright red once the timeframe for that activity has lapsed. Site personnel, our years of experience attest, don’t like to see red — they know their CRA will also “see red” and will be soon demanding to know what’s happening with the subject in question! Users are thus motivated to eliminate this warning color from their table views by entering the necessary screen fail activity.

The same applies to receiving shipments. Acknowledging receipt is a key factor in keeping site drug inventories accurate and up to date within the IRT. The system can assist by turning red the Sent Date of any shipment that was sent more than X days previously and has not yet been modified to a status of Received.

When selecting an IRT, Program Managers should give careful thought to the application of creative designs that can help solve some of these common problems of clinical trials.

Getting Data Sooner With IRT

Case Studies

The Challenge:

A classic problem in the conduct of a clinical trial is how to motivate site personnel to enter their clinical data in a timely fashion. What can be done to enable project personnel to receive study data sooner?

Managing Users in the IRT

Case Studies

Managing Users is one of the key functions of an IRT system in a clinical trial. Typically, IRTs provide the important subject randomization and drug supply management activities for the study. Assigning access to the array of permissions that determine what each user can see and not see in each arena must be foolproof, easy to set up, speedy to change and maintain, and friendly when it comes to adding and subtracting Users throughout the life of the study.

Custom User Roles …

Case Studies

Problem:

You’ve got a complicated study that, for ease of conduct, will require two special types of user roles not offered in your current IRT system. One is a kind of Project Observer who can access the same data your Project Managers can access, i.e., users and sites, resupply settings, screening limits, etc., but with a View-Only perspective. Your second need is for two types of Site Investigators, one with the power to unblind subjects in cases of emergency, one without that power. Your current IRT allows for only one type of PI role. What to do?
Solution:

Veracity Logic’s IRT is built on an easily configurable platform which enables creation of new User Roles to fit study needs without timeline-busting custom coding. In the above case, the creation of a Clinical Project Observer with a specified set of permissions can be handled on a configuration basis via a User Roles table, as can the creation of a Blinded Investigator role. During study startup and throughout the trial, user permissions are managed by means of a user-friendly User Management module in the project system.

In other words, Veracity Logic’s IRT gives you the power and flexibility you need to meet real-life scenarios with real-life solutions.